Russia’s Federal Medical Biological Agency expects to obtain temporary registration for its birch pollen allergy vaccine Allergarda – one of the most common seasonal allergens in central Russia – in September 2026, FMBA head Veronika Skvortsova said on Channel One. Temporary registration would allow widespread use of the drug before the full clinical trial cycle is completed.
According to Skvortsova, the two-year Phase III clinical trial of the vaccine will only be completed in September 2027. However, a temporary registration already obtained will allow the drug to be used in medical practice without waiting for the full trial to finish. This mechanism is usually applied to socially significant or highly effective drugs when safety data have been confirmed.
The development of a vaccine to treat birch pollen allergy was first announced in 2023. It was created by scientists at the FMBA’s Institute of Immunology together with colleagues from the Medical University of Vienna. After the trials are completed, the drug may be added to the National Immunisation Schedule.
It is expected that no more than five injections will be enough to eliminate the allergic reaction, whereas existing treatments require up to 30 administrations. Unlike conventional allergen-specific immunotherapy, which takes about three years, the vaccine treatment course is designed for two seasons. The developers say this approach will shorten therapy duration and improve patient adherence.
